Acute Myeloid Leukemia Clinical Trial

A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias

Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations
Performance status greater than or equal to (>=) 50 by lansky scale (for participants less than [<] 16 years of age) or >=50 percent (%) karnofsky scale (for participants >=16 years of age)
Estimated or measured glomerular filtration rate >= 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) based on the bed side schwartz formula

Exclusion Criteria:

Received an allogeneic hematopoietic transplant within 60 days of screening
Active acute graft-versus-host disease of any grade or chronic graft-versus-host which is not well-controlled
Received immunosuppressive therapy post hematopoietic transplant within 30 days of enrollment
Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile myelomonocytic leukemia
Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any other known bone marrow failure syndrome
Prior exposure to menin-KMT2A inhibitors
Prior cancer immunotherapy (ie [that is], Chimeric Antigen Receptor-T Cell Therapy [CAR-T], inotuzumab, gemtuzumab ozogamicin) within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05521087

Recruitment Status:

Not yet recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 7 Locations for this study

See Locations Near You

Hôpital Jeanne de Flandre
Lille , 59000, France
Institut D'Hematologie Et D'Oncologie Pediatrique
Lyon Cedex 08 , 69008, France
Hopital trousseau- APHP
Paris , 75012, France
Hôpital Robert Debré
Paris , 75019, France
CHU de Rennes - Hôpital Sud
Rennes Cedex 2 , 35200, France
CHU de Toulouse Hopital des Enfants
Toulouse , 31300, France
Centre Hospitalier Universitaire de Nancy - Hôpital Central
Vandœuvre-lès-Nancy , 54500, France

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05521087

Recruitment Status:

Not yet recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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